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Orana Vietnam Co., Ltd

⚠️ Moderate Risk

FEI: 3008008297 • Ho Chi Minh, Ho Chi Minh • VIETNAM

FEI

FEI Number

3008008297

📍

Location

Ho Chi Minh, Ho Chi Minh

🇻🇳

Country

VIETNAM
🏢

Address

Lot 3 (Former Known As Lot 3-5, Area F1), Street D4, Area A5, Tan Thoi Hiep Industrial Zone, Hiep Thanh Ward, District 12, Ho Chi Minh, Ho Chi Minh, Vietnam

Moderate Risk

FDA Import Risk Assessment

35.1
LowModerateHighCritical

This firm has a moderate history of FDA import refusals. Some attention may be warranted.

Statistics

1
Total Refusals
3
Unique Violations
5/31/2023
Latest Refusal
5/31/2023
Earliest Refusal

Score Breakdown

Violation Severity
53.3×40%
Refusal Volume
11.2×30%
Recency
47.1×20%
Frequency
10.0×10%
How is this score calculated?

Proprietary Algorithm

  • 40% Violation Severity — AI-assessed (1-10)
  • 30% Refusal Volume — Logarithmic scale
  • 20% Recency — Decays over 5 years
  • 10% Frequency — Refusals per year

© ImportRefusal.com Original Analysis

Violation Summary

111×

UNSAFE COL

The article appears to be, or to bear or contain a color additive which is unsafe within the meaning of Section 721(a).

3211×

LACKS N/C

The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(e)(2) of the FD&C Act in that the food is in package form and the label fails to bear an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count in accordance with Section 403(e)(2) of the FD&C Act.

3281×

USUAL NAME

The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(i)(1) of the FD&C Act in that the label fails to bear the common or usual name of the food, if any there be.

Refusal History

DateProductViolationsDivision
5/31/2023
20BGY14STRAWBERRIES, DRIED OR PASTE
11UNSAFE COL
321LACKS N/C
328USUAL NAME
Division of West Coast Imports (DWCI)

Frequently Asked Questions

What is Orana Vietnam Co., Ltd's FDA import refusal history?

Orana Vietnam Co., Ltd (FEI: 3008008297) has 1 FDA import refusal record(s) in our database, spanning from 5/31/2023 to 5/31/2023.

What is an FEI number?

FEI stands for Firm Establishment Identifier. It's a unique number assigned by the FDA to identify establishments that manufacture, process, pack, or hold food, drugs, medical devices, or other FDA-regulated products. Orana Vietnam Co., Ltd's FEI number is 3008008297.

What types of violations has Orana Vietnam Co., Ltd received?

Orana Vietnam Co., Ltd has been cited for 3 different violation type(s). Common FDA violations include adulteration (unsafe or unsanitary products), misbranding (incorrect or misleading labels), and regulatory non-compliance.

Where does this information about Orana Vietnam Co., Ltd come from?

All FDA import refusal data for Orana Vietnam Co., Ltd is sourced from the official FDA Data Dashboard (datadashboard.fda.gov), a public government database maintained by the U.S. Food and Drug Administration.

Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.